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MassTrak™

by Waters Corporation United States EUDAMEDGUDID

Ref 186008096IVD, 186008647IVD, 186008442IVD, 186010568IVD, 186010567IVD

Product code JIXEMDN W0102060309

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081677602VTDKIT0608D9 Basic UDI-DIDate15 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00816776020377 UDI-DIDate5 Dec 2023ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
MassTrak™ EUDAMED
MassTrak™ Steroid Optimization Mix EUDAMED
MassTrak™ Steroid Internal Standard Mix EUDAMED
MassTrak GUDID
Generic Name
Multiple steroid hormone IVD, control
Device Name
Masstrak™ Vitamin D Kit
MassTrak™ Endocrine Product Family
Model / Ref / Catalog
186008096IVD, 186008647IVD, 186008442IVD, 186010568IVD, 186010567IVD
Primary DI / UDI-DI
00816776020377, 00816776020407, 00816776020384, 00816776020582, 00816776020599
Basic UDI-DI
081677602VTDKIT0608D9, 081677602MSTKENDOB5
FDA Product Code
JIX
EMDN Code
W0102060309, W0101050299,W0101050399
GMDN Term
Multiple steroid hormone IVD, control
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
862.1150
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000025801
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Waters Corporation

See all devices from Waters Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues NoEUDAMEDYesEUDAMED
  • Reagent
  • Professional Testing YesEUDAMEDNoEUDAMED
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
Other properties (18)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (7)

  • EUDAMED 2a8a7ab0-73c6-4bfe-8d5b-868f2d5b143e 61 fields · synced 22 Oct 2026
  • EUDAMED 00816776020407|081677602VTDKIT0608D9 61 fields · synced 16 May 2026
  • EUDAMED 00816776020384|081677602VTDKIT0608D9 61 fields · synced 17 May 2026
  • EUDAMED 00816776020582|081677602MSTKENDOB5 61 fields · synced 17 May 2026
  • FDA UDI b831df1e-5e86-40a5-87b6-b3ce8073dc07 36 fields · synced 30 May 2026
  • FDA UDI fb5b9307-d89a-4dce-aa54-67b84582b37c 36 fields · synced 30 May 2026
  • EUDAMED 00816776020599|081677602MSTKENDOB5 61 fields · synced 29 Jul 2026